Sage confirms suspension of 2 depression trials after PhIII flop; Esperion follows up maiden approval with combo OK
→ In the wake of a flop in the crucial Phase III MOUNTAIN study, Sage Therapeutics confirmed in its quarterly update that it’s suspended enrollment in two other pivotal trials for the oral depression drug SAGE-217 (or zuranolone) as it awaits guidance from the FDA. While REDWOOD (measuring relapse) and RAINFOREST (for patients with both major depressive disorder and insomnia) are on hold pending amendments, though, the open-label SHORELINE has completed enrollment. CEO Jeff Jonas remained tight-lipped about what specific tweaks they are considering for the program, reiterating only there have been issues with compliance and room for a higher dose.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.